Job Summary: Meet's client is seeking a motivated and detail-oriented Quality Compliance Associate to support their Quality Compliance processes. This role is critical for ensuring inspection readiness, managing self-inspection programs, and enhancing data integrity initiatives. The Quality Compliance Associate will work closely with cross-functional teams to drive continuous improvement in quality systems and maintain compliance with regulatory standards.
Key Responsibilities:
- Assist in the Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities.
- Support or lead initiatives aimed at improving quality systems (procedures and systems) to enhance organizational effectiveness and ensure compliance with quality assurance and regulatory requirements (cGMP, ICH).
- Strictly adhere to cGMP guidelines and procedures; escalate any non-compliance concerns to management promptly.
- Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary to facilitate quality compliance initiatives.
- Interpret and apply relevant regulatory guidelines and directives including 21 CFR, USP, EP, JP, and ICH to ensure compliance.
Qualifications:
- Bachelor’s degree in a scientific discipline or a related field.
- 4-6 years of experience in a biologics manufacturing environment with a focus on Manufacturing, Quality Control, and Quality Management System (QMS) processes.
